Surgical Treatment of High Perianal Fistulas

Not Applicable

• Conditions: Anal Fistula; Rectal Fistula

• Registration Number: NCT01997645
• Lead Sponsor: University Hospital Hradec Kralove

Brief Summary

Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. According to Parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously.

Therefore sphincter preserving procedures should be preferred in these cases. Rectal advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. However, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review.

Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple sphincter preserving technique. The success rate varies between 40-95% with low overall incontinence rate (6%).

The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment of high perianal fistulas.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-11
• Study Start: 2013-11
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-22
• Last Update Submitted: 2013-11-22
• Study First Posted: 2013-11-28
• Last Update Posted: 2013-11-28
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients aged 18 years old or older
• Diagnosis of simple intersphincteric or transsphincteric fistula
• Patients able to comply with the study protocol as per investigator criteria
• Signed and dated informed consent by the patient
• Absence of any exclusion criteria

Exclusion Criteria

• Recurrent anal fistula
• Suprasphincteric, low subcutaneous fistula
• Multiple fistulas
• Posttraumatic fistula
• Perianal hidradenitis
• Fistula arises from other than cryptoglandular origin
• Previous anal surgery except of abscess
• Inflammatory Bowel Disease
• History of fecal incontinence
• Rectal prolapse
• Malignant disease and life expectancy of less than 1 year, or chemotherapy and radiotherapy less than six months prior enrolment
• HIV infection
• Pregnancy
• Participation in another clinical trial less than one month prior to enrolment, or involvement in another trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence rate	One year	Fistula recurrence will be defined according to AGA (American Gastroenterological Association) criteria as a purulent secretion from external fistula opening followed the compression.; Fistula recurrence will be confirmed by evaluation under anesthesia (followed by drainage).

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	14 days	Postoperative pain will be assessed 4 times per day during the first 2 postoperative days (VAS - visual analogue scale), after that 3 times per day over next 14 days (patient's diary).
Pre- and postoperative continence	One year	Pre- and postoperative continence will be evaluated with Wexner score.
Postoperative morbidity	One month	Will be evaluated according to Clavien-Dindo classification.
Quality of life	One year	For quality of life evaluation SF-36 questionnaire will be used.

Trial Locations

Locations (3)

Department of Surgery, Charles University, Faculty of Medicine and University Hospital; 🇨🇿 Hradec Kralove, Czech Republic

Departement of Surgery, District Hospital; 🇨🇿 Novy Jicin, Czech Republic

Departement of Surgery, Military University Hospital; 🇨🇿 Prague, Czech Republic